Label: SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH- ethyl alcohol liquid
- NDC Code(s): 12745-850-01, 12745-850-02, 12745-850-03
- Packager: Medical Chemical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 16, 2020
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- Purpose
- Active Ingredients
- Inactive Ingredients
- Warnings
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Warnings
Danger: Highly flammable liqid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.
- Directions
- Uses
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12745-850 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 55.34 g in 100 mL DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4) DIAZOLIDINYL UREA 0.167 g in 100 mL Inactive Ingredients Ingredient Name Strength SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ) 0.02 g in 100 mL CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 4 g in 100 mL CETYL LACTATE (UNII: A7EVH2RK4O) 0.5 g in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g in 100 mL DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.29 g in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12745-850-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/23/2020 2 NDC:12745-850-02 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/23/2020 3 NDC:12745-850-03 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/23/2020 Labeler - Medical Chemical Corporation (008496861) Registrant - Medical Chemical Corporation (008496861) Establishment Name Address ID/FEI Business Operations Medical Chemical Corporation 008496861 manufacture(12745-850)